You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 25, 2024

Details for New Drug Application (NDA): 072621

✉ Email this page to a colleague

« Back to Dashboard

NDA 072621 describes ACETYLCYSTEINE, which is a drug marketed by Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Indoco, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Steriscience Speclts, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane, and is included in twenty-three NDAs. It is available from fourteen suppliers. Additional details are available on the ACETYLCYSTEINE profile page.

The generic ingredient in ACETYLCYSTEINE is acetylcysteine. There are three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

Summary for 072621

Tradename:	ACETYLCYSTEINE
Applicant:	Roxane
Ingredient:	acetylcysteine
Patents:	0

Medical Subject Heading (MeSH) Categories for 072621

Antiviral Agents
Expectorants
Free Radical Scavengers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION, ORAL			Strength	10%
Approval Date:	Sep 30, 1992	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.